Spinous process spacer hammock

ABSTRACT

A spinal distractor for distracting opposed vertebrae in which a pair of elements are threadably connected by a screw having opposing threads, wherein actuating the screw spreads the elements apart and pushes the vertebrae apart.

CONTINUING DATA

This continuation application claims priority from co-pending U.S.patent application Ser. No. 16/012,316, entitled “Spinous Process SpacerHammock”, Slivka et al., filed Jun. 19, 2018, which claims priority fromU.S. Ser. No. 15/648,804, entitled “Spinous Process Spacer Hammock”,Slivka et al., filed Jul. 13, 2017, from U.S. patent application Ser.No. 14/878,048, entitled “Spinous Process Spacer Hammock”, Slivka etal., filed Oct. 8, 2015, and from U.S. patent application Ser. No.11/770,802, entitled “Spinous Process Spacer Hammock”, Slivka et al.,filed Jun. 29, 2007, the specifications of which are incorporated byreference in their entireties.

BACKGROUND OF THE INVENTION

Patients suffering from low back or leg pain frequently have stenosis ofthe vertebral and/or neural foramen that constricts their spine-relatednerves. It has been shown that applying traction to the spinousprocesses may alleviate this pain and several devices have beendeveloped that accomplish this. However, many of these devices areeither difficult to implant, do not stay in place, or wear away the boneof the spinous process due to poor conformance of the device.

US Published Patent Application No. US20060122620 (“Kim I”) discloses aposterior element distraction system for implantation at a spinal motionsegment comprising a superior vertebra, an inferior vertebra, eachvertebra comprising a posterior element comprising a spinous process,laminal portions and a set of facet joints, and further comprising aninterspinous space between the spinous processes, the system comprising:at least one lateral member for positioning on a side of the spinalmotion segment and outside the interspinous space, wherein the at leastone lateral member has an unexpanded configuration and an expandedconfiguration; and first and second transverse members extendingtransversely from the at least one lateral member, wherein when thesystem is operatively implanted at a spinal motion segment and the atleast one lateral member is in an expanded configuration, the transversemembers are caused to contact a portion of either the superior orinferior posterior elements thereby providing distraction between thesuperior and inferior posterior elements.

US Published Patent Application No. US20060085070 (Kim II) discloses adevice for stabilizing at least one spinal motion segment comprising afirst vertebra having a first spinous process and a second vertebrahaving a second spinous process, the device comprising: an undeployedconfiguration having an axial dimension and a radial dimensionsubstantially transverse to the axial dimension; and a deployedconfiguration having an axial dimension and a radial dimensionsubstantially transverse to the axial dimension; wherein the radialdimension of the undeployed configuration is less than the radialdimension in the deployed configuration.

US Published Patent Application No. 2005-0203512 (“Hawkins”) disclosesan interspinous implant for insertion into an interspinous space betweena first and second spinous process, the first spinous process having afirst and second side, the implant comprising: a) a first base having aside surface adapted for fixation to a first side of the first spinousprocess, b) a second base having a side surface adapted for fixation toa second side of the first spinous process, c) a first flexible ligamenthaving a first end connected to the first base and a second endconnected to the second base.

U.S. Pat. No. 6,582,433 (Yun) discloses a device and method thatimmobilizes the vertebral bodies by immobilizing the respective spinousprocess extending therefrom. The device contains a spacer extending froma body with the spacer adapted to be positioned between adjacent spinousprocesses so that the spacer may be located close to the spine. A strapconnected with the body is designed to engage the spinous processes,such that the device may be adjusted to be positioned about the spinousprocesses. The device ensures that the spacer remains positioned betweenadjacent spinous processes. The method to insert the device minimizesdestruction to body tissue, thus it is less traumatic to the patient andallows for the patient to recover from the procedure faster thanconventional methods.

It is an object of the present invention to provide an interspinousspacer that is easy to implant, remains in place after it is implanted,and whose excellent conformance to the adjacent spinous processesprevents wearing away of the adjacent spinous processes during use.

SUMMARY OF THE INVENTION

In a first embodiment of the present invention, there is provided aninterspinous spacer that comprises a flexible strap or ligament that isthreaded through two slotted plates positioned on either side of thespinous processes and a means for tensioning the strap and holding it inplace once the desired distraction has been achieved. Distraction of thespinous processes is achieved by locating the slots on the straps suchthat the distance between the slots on each plate is larger than thedistance between the spinous processes. Adjustable distraction of thespinous processes may also be achieved by varying the level of tensionin the strap. Increasing the level of tension in the strap increases thedistraction of the spinous processes (up to the distance between theupper and lower throughholes), while decreasing the level of tensiondecreases the distraction. In addition, as the ligament is tensioned,the two braces automatically become snugly opposedly positioned againstthe sides of the spinous processes, thereby helping to keep the devicefrom migrating during use.

In another embodiment, the spacer comprises two straps or ligaments, onelocated at the cranial and one at the caudal portions of the device,with each strap being fixed to the respective inner surfaces of twoplates positioned on opposing sides of the spinous processes. For thisembodiment, there is preferably a centrally located distance adjustmentelement that connects the two plates and may be adjustable in amedial-lateral direction such that the adjustment changes the tension ofthe straps and thereby enables distraction of the spinous processes. Inone preferred embodiment, the central distance adjustment element is athreaded rod and the plates have threaded holes for mating with thethreaded rod. Preferably, the opposed holes are threaded in the oppositedirection (right hand versus left hand threads) such that upon turningthe threaded rod, the plates will move either away from each other ortowards each other, thus either tightening or loosening the strap.

DESCRIPTION OF THE FIGURES

FIG. 1 discloses a first embodiment of the interspinous spacer of thepresent invention.

FIGS. 2a-2f disclose a method of implanting the spacer of FIG. 1.

FIG. 3 discloses a preferred first embodiment of the interspinous spacerof the present invention.

FIG. 4 discloses a second embodiment of the interspinous spacer of thepresent invention.

FIG. 5 discloses an embodiment of the present invention having atransverse bolt.

FIG. 6 discloses an embodiment of the present invention having aprosthetic ligament connecting to each plate and extending up and overthe upper spinous process.

FIG. 7 discloses an embodiment of the present invention having twoJ-shaped plates.

FIG. 8 discloses a crimp block revision tool of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Now referring to FIG. 1, there is provided an interspinous spacercomprising:

a) a first brace 1 having an upper throughhole 3 and a lower throughhole5,

b) a second brace 11 having an upper throughhole 13 and a lowerthroughhole 15,

c) a ligament 21 having a first end 23 and a second end 25,

wherein the ligament extends from the upper throughhole of the firstbrace through the upper throughhole of the second brace, then throughthe lower throughhole of the second brace, then through the lowerthroughhole of the first brace, and

wherein the first end of the ligament is in mechanical connection withthe second end of the ligament between the upper throughhole and a lowerthroughhole of the first brace.

Now referring to FIGS. 2a-2f , the spacer is assembled in situ asfollows: First, and now referring to FIG. 2a , the ligament is drawnthrough each of the upper and lower holes of a first brace, with eachend of the ligament exiting the respective holes in the same direction.Next, and now referring to FIG. 2b , the ligament and brace combinationis inserted on a first side of the spine, is passed through the spacebetween adjacent spinous processes SP and exits on the second side ofthe spine. The first brace is then oriented so that the portion of theligament that runs between the holes of the first brace is located onthe outer face 7 of the first brace, while the inner face 9 abuts thespinous processes.

Next, if needed, each end of the ligament is passed back through thespace between the adjacent interspinous processes and extended back intothe first half of the spine.

Next, and now referring to FIG. 2c , one end of the ligament is passedthrough the upper throughhole of the second brace, while the second endof the ligament is passed through the lower throughhole of the secondbrace. Each end of the ligament enters its respective throughhole fromthe same inner face 19 of the second brace.

Next, and now referring to FIG. 2d , the second brace is then insertedinto the first half of the spine and oriented so that its inner face 19abuts the spinous processes, and the ends of the ligament are closer tothe outer face 17 of the second brace.

Next, and now referring to FIG. 2e , the respective end portions of theligament are then pulled in unison so as to create tension in theligament and thereby cause distraction of the upper and lower spinousprocesses. Since the distance D between the upper and lower slots oneach plate (shown in FIG. 2c ) is larger than the gap G between thespinous processes (shown in FIG. 2c ), distraction is achieved when theligament is tensioned.

Lastly, and now referring to FIG. 2f , the respective end portions ofthe ligament are then mechanically connected by a connection means 27(such as a crimpable tube) to make a permanent and continuous loop thatextends through each of the upper and lower throughholes of each brace.

Therefore, in accordance with the present invention, there is provided amethod of implanting an interspinous implant, comprising the steps of:

a) implanting a first brace having an upper throughhole and a lowerthroughhole on a first side of a spinous process,

b) implanting a second brace having an upper throughhole and a lowerthroughhole on a second side of the spinous process,

c) passing a ligament from the upper throughhole of the first bracethrough the upper throughhole of the second brace,

d) passing the ligament from the upper throughhole of the second bracethrough the lower throughhole of the second brace,

e) passing the ligament from the lower throughhole of the second bracethrough the lower throughhole of the first brace, and

f) mechanically connecting a first end of the ligament with a second endof the ligament between the upper throughhole and a lower throughhole ofthe first brace.

In some embodiments, the first brace is implanted through a firstincision on the first side of the spinous process, and the second firstbrace is implanted through the first incision. In some embodiments, thefirst brace is implanted through a first incision on the first side ofthe spinous process, and the second first brace is implanted through asecond incision on the second side of the spinous process.

In one preferred embodiment, the means for tensioning the strapcomprises a wheel around which the strap can wind as the wheel isturned, thus creating the tension in the strap. The wheel may be eithera part of the implant or a part of an instrument.

Once the desired distraction is achieved, the position may be locked inplace either by locking the wheel (in the case where the wheel is partof the implant) or by securing a blocking member on the strap. One suchblocking member could be a metallic sleeve that is crimped into place,or a hardenable polymer formed in place. In some embodiments, the strapmay be crimped and then glued in place. In other embodiments, the strapmay be tied and then glued in place.

Now referring to FIG. 3, there is provided an interspinous spacercomprising:

a) a first brace 31 having an upper throughhole 33, a lower throughhole34, an intermediate section 35, and a wheel 36 and a crimpable tube 37each mechanically connected to the intermediate section

b) a second brace 39 having an upper throughhole 41 and a lowerthroughhole 43,

c) a ligament 45 having a first end 47 and a second end 49,

wherein the ligament extends from the wheel through upper throughhole ofthe first brace, through the upper throughhole of the second brace, thenthrough the lower throughhole of the second brace, then through thelower throughhole of the first brace, and into the crimpable tube.

Now referring to FIG. 4, there is provided an interspinous spacercomprising:

a) a first brace 51 having an upper end portion 53, a lower end portion55, and an intermediate portion 57,

b) a second brace 61 having an upper end portion 63, a lower end portion65 and an intermediate portion 67,

c) a distance adjustment element 71 connected to each of theintermediate portions,

d) an upper ligament 81 having a first end 83 and a second end 85,

e) a lower ligament 91 having a first end 93 and a second end 95,

wherein the upper ligament connects the upper end portion of the firstbrace to the upper end portion of the second brace, and

wherein the lower ligament connects the lower end portion of the firstbrace to the lower end portion of the second brace.

Preferably, the distance adjustment element comprises a threaded rod 73having a first end 75 threaded in one direction and a second end 77threaded in a second direction, and the intermediate portion of eachbrace has a threaded hole 59, 69 adapted for threaded mating with thethreaded rod. More preferably, a first threaded hole is threaded in afirst direction while a second threaded hole is threaded in a secondopposite direction.

In use, the device of FIG. 4 is implanted so that the first brace islocated on a first side of the spinous processes, the second brace islocated on a second side of the spinous processes, and the distanceadjustment element is located in the gap between the spinous processes.The distance adjustment element is then actuated to decrease thedistance between the braces. As the distance between the bracesdecreases, the two braces automatically become snugly opposedlypositioned against the spinous processes, thereby helping to keep thedevice from migrating during use. As the distance increases, the twoligaments automatically become tensioned and press against the innerportion of the spinous processes, thereby causing distraction.

Preferably, when the strap or ligament contacts the spinous process, itis relatively wide in the anterior-posterior direction to maximizecontact with the spinous processes, thus minimizing stress risers andthereby the potential wear of the strap or the bone. Thus, the strappreferably has a cross-section having a height and a width, wherein thewidth is greater than the height. Additionally, a protective guard maybe placed over the contacting portions of the spinous processes in orderto minimize this wear. Alternatively, a protective sleeve may be placedover the strap in the region where it interfaces with the bone. Also,the strap is preferably constructed of a wear-resistant material such asultra-high molecular weight polyethylene. Other biocompatible materialsmay be used as well, including polyethylene terephthalate,polyetheretherketone (PEEK), polyurethane, or bioabsorbable materialssuch as poly(L-lactic acid), poly(glycolic acid) and other biocompatiblematerials known in the art. The strap may be constructed by weaving,braiding or knitting fibers or fiber bundles into a typical fabric form.In one preferred embodiment, a three-dimensional weaving pattern is usedto create a thin and wide strap.

In some embodiments, more than one strap may be used. The straps mayalso be made of metal or elastormeric. They can be rigid or flexible.They can be made of a fabric or non-fabric material. They may comprise abelt, a weave, a composite or a laminate.

Some embodiments of the present invention may comprises a belted strap.An alternative embodiment to a woven or braided fabric ligament would bea composite or homogeneous belt of material. Similar to an automotivebelt that uses grooves or ribs of material to help transfer load, thebelted strap could use composite internal materials, potting compounds,or external surface features to enhance system performance. For example,a composite belted ligament could have a layer of steel or Kevlar™material that would help to prevent material creep. Similarly, surfacefeatures on the belt could articulate with the spinous processes toprevent device migration or assist device placement.

As noted above, the device of the present invention may comprisemultiple ligaments. There are many benefits to having multiple ligamentsin the device of the present invention. One ligament with across-sectional width that is significantly larger in dimension than itscross-sectional thickness constrains the width of the ligament relativeto the side plate width. For a plate where the ligament passes through athrough-hole, the plate must be wider than the ligament unless it isacceptable to compress or fold the ligament where it passes through theplate. Another benefit to incorporating a plurality of ligaments betweenthe side plates is redundancy. If one ligament within the pluralityfails, the other ligaments can assume the load. Multiple ligaments cantravel multiple pathways from one side plate to the other sideplate—much like a traditional hammock. This splay of ligaments canenable the mechanical load to be spread over a larger area of thespinous process. A splay of ligaments may also allow for differentialtightening between the ligaments. Differential tightening can be used topreferentially load bone at different regions of the spinous process.For example, three ligaments could be applied where the majority of theload is carried on the first and last ligaments and the middle ligamentis only used in a modest capacity. Some degree of bone resorption andligament settling can be expected. The first and third ligaments wouldcreate slight depressions in the local bone due to overload andsubsequent Wolff's Law remodeling. This overload would be resolved bythe second central ligament assuming more load during the settling. Apositive consequence of this arrangement is that the device is nowpositively fixed in place between the spinous processes due to theremodeled bone depressions that prevent device migration. A multiplicityof ligaments might also mitigate the consequences of this situation by“over-loading” some ligaments with the expectation that they will causebone resorption while the other ligaments osseo-integrate and assume amore “natural” load bearing status. Multiple smaller ligaments ofmaterial are easier to handle from a surgical perspective than one largestrap or belt of material. Smaller ligaments would be more akin totraditional sutures. Multiple ligaments can be tied-off like sutures,and systems for fixing the ultimate length of these small ligaments is,again, more akin to the systems used to fix the length of traditionalbraided suture materials.

The plates are preferably constructed of biocompatible, wear-resistantmaterials known in the art such as titanium, stainless steel, PEEK, orcarbon fiber-reinforced PEEK. The plates may be constructed such thatthey provide some flexibility once implanted—by either using moreflexible materials such as PEEK, or making the plates sufficiently thinto allow for some flexing. For embodiments where the strap threadsthrough the plates, the slots or holes in the plate preferably haverounded edges to prevent wear of the strap on the plate.

In preferred embodiments, each plate is manufactured from a materialthat possesses the desirable strength and stiffness characteristics foruse as an interspinous spacer. The plates of the present invention maybe made from any non-resorbable material appropriate for human surgicalimplantation, including but not limited to, surgically appropriatemetals, and non-metallic materials, such as carbon fiber composites,polymers and ceramics.

The plates can be made of any structural biocompatible materialincluding non-resorbable polymers (CFRP, PEEK, UHMWPE), resorbables(such as PLA, PLGA, PGA), metallics (SS, Ti-6Al-4V, CoCr,) and ceramics.The plate material is preferably selected from the group consisting ofmetal and composite (such as PEEK/carbon fiber).

If a metal is chosen as the material of construction for a component,then the metal is preferably selected from the group consisting oftitanium, titanium alloys (such as Ti-6Al-4V), chrome alloys (such asCrCo or Cr—Co—Mo) and stainless steel.

The plate component may have teeth; porous beaded surfaces to encouragebony ingrowth; or fixation features on the ingrowth surfaces to preventdevice migration.

If a polymer is chosen as a material of construction for a component,then the polymer is preferably selected from the group consisting ofpolyesters, (particularly aromatic esters such as polyalkyleneterephthalates, polyamides; polyalkenes; poly(vinyl fluoride); PTFE;polyarylethyl ketone PAEK; and mixtures thereof.

If a ceramic is chosen as the material of construction for a component,then the ceramic is preferably selected from the group consisting ofalumina, zirconia and mixtures thereof. It is preferred to select analumina-zirconia ceramic, such as BIOLOX Delta™, available from CeramTecof Plochingen, Germany.

In some embodiments, the first plate consists essentially of a metallicmaterial, preferably a titanium alloy or a chrome-cobalt alloy. In someembodiments, the second plate consists essentially of the same metallicmaterial as the first plate.

In some embodiments, the components are made of a stainless steel alloy,preferably BioDur® CCM Plus® Alloy available from Carpenter SpecialtyAlloys, Carpenter Technology Corporation of Wyomissing, Pa.

The plates may be rigid or flexible.

In some embodiments, the plates are made from a composite comprisingcarbon fiber. Composites comprising carbon fiber are advantageous inthat they typically have a strength and stiffness that is superior toneat polymer materials such as a polyarylethyl ketone PAEK.

In some embodiments, each plate is made from a polymer composite such asa PEKK-carbon fiber composite.

Preferably, the composite comprising carbon fiber further comprises apolymer. Preferably, the polymer is a polyarylethyl ketone (PAEK) orpolyphenylene. More preferably, the PAEK is selected from the groupconsisting of polyetherether ketone (PEEK), polyether ketone ketone(PEKK) and polyether ketone (PEK). In preferred embodiments, the PAEK isPEEK.

In some embodiments, the carbon fiber comprises between 1 vol % and 60vol % (more preferably, between 10 vol % and 50 vol %) of the composite.In some embodiments, the polymer and carbon fibers are homogeneouslymixed. In others, the material is a laminate. In some embodiments, thecarbon fiber is present in a chopped state. Preferably, the choppedcarbon fibers have a median length of between 1 mm and 12 mm, morepreferably between 4.5 mm and 7.5 mm. In some embodiments, the carbonfiber is present as continuous strands.

In especially preferred embodiments, the composite comprises:

a) 40-99% (more preferably, 60-80 vol %) polyarylethyl ketone (PAEK),and

b) 1-60% (more preferably, 20-40 vol %) carbon fiber,

wherein the polyarylethyl ketone (PAEK) is selected from the groupconsisting of polyetherether ketone (PEEK), polyether ketone ketone(PEKK) and polyether ketone (PEK).

In some embodiments, the composite consists essentially of PAEK andcarbon fiber. More preferably, the composite comprises 60-80 wt % PAEKand 20-40 wt % carbon fiber. Still more preferably, the compositecomprises 65-75 wt % PAEK and 25-35 wt % carbon fiber.

In some embodiments, the holes of the plates may be replaced by positivefeatures such as rungs, that can help anchor the ligament.

In some embodiments, the device of the present invention contains extrafeatures that insure that the device stays in place when set against thespinous processes. FIG. 5 discloses an embodiment of the presentinvention having a transverse bolt 101 extending through a throughhole102 in each of the plates. FIG. 6 discloses an embodiment of the presentinvention having a prosthetic ligament 103 connected to each plate andextending up and over the upper spinous process. FIG. 7 discloses anembodiment of the present invention having two J-shaped plates 111, 113that encircle the spinous processes.

FIG. 8 discloses a crimp block revision tool 115 of the presentinvention. Generally, the device's ligament is permanently fixed at acertain length intraoperatively. However, it is expected that asituation may present in some patients postoperatively that requiresfurther shortening of the ligament. To address this need topost-operatively shorten an implanted ligament, an implantable crimpblock 115 is provided that captures a greater amount of ligamentmaterial between two points than is represented by the linear distancebetween those points. For example, the ligament material must travel atortuous pathway between the two points such that the length of tethermaterial between the points is greater than the fixed linear distancebetween the points. In the embodiment of FIG. 8, two hinged plates withstand-offs of height A placed along the length of the plate at adistance 2B are closed around a ligament of material. The stand-offsnest together, thereby creating a tortuous pathway for the interveningligament material. For a plate with one central stand-off of height Athat nests between two stand-offs placed at the ends of the other plateof length 2B (total crimp block length of 2B), the amount of ligamentmaterial captured between these stand-offs is 2*(A²+B²)^(1/2)>2*B.Additional stand-offs can be added. Thus, the reduction in ligamentlength for a crimp block containing N stand-off segments of height Awith distance 2*B between the standoffs is characterized asΔ1=N*2*[(A²+B²)^(1/2)−B].

Preferably, the device of the present invention is placed between thespinous processes using a minimally invasive approach that spares thesupraspinous ligament. For the first embodiment described above having acontinuous ligament, the first plate with the strap woven through isthreaded through the muscle, bone and ligamentous structures from thecontralateral side, followed by threading of the second plate with thestrap woven through to the ipsilateral side. The tensioning and positionlocking can then be accomplished through the same insertion approachused to place the plates. Thus, the entire procedure can be accomplishedusing a percutaneous technique.

Preferably, the device of the present invention is used in patients whohave stenosis of the vertebral and/or neural foramen that constrictstheir spine-related nerves and thereby suffer from low back or leg pain.

We claim:
 1. An interspinous spacer comprising: a) a first brace havingan upper throughhole and a lower throughhole, b) a second brace havingan upper throughhole and a lower throughhole, c) a single strap having afirst end and a second end, wherein a first portion of the strap islocated between the upper throughhole of the first brace and the upperthroughhole of the second brace, wherein a second portion of the strapis located between the lower throughhole of the first brace and thelower throughhole of the second brace, wherein a distance D between theupper and lower througholes on each brace is larger than a smallestdistance between the first strap portion and the second strap portion,and wherein no portion of the strap passes through bone.